Kim Gale  |  August 11, 2017

Category: Legal News

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Pradaxa bleeding side effects anticoagulant emergency ambulanceBlood thinner Pradaxa, made by Boehringer Ingelheim, has been linked to serious side effects that can cause death.

The FDA approved Pradaxa as an anticoagulant in October 2010 to reduce the chances of a stroke in patients with atrial fibrillation, a type of irregular heartbeat that occurs when or both upper heart chambers function erratically.

Clotting occurs more frequently in people who have atrial fibrillation because the heart beats so fast and erratically that the blood isn’t pushed completely out of the heart, which leads to an increased risk of stroke that is five times that of the general population. The blood thinner Pradaxa can reduce the risk of stroke by preventing those clots from forming.

Although atrial fibrillation itself is not life-threatening, the strokes caused by the condition are more likely to be severe, with a higher incidence of death and disability.

Blood Thinner Pradaxa Linked to Internal Bleeding

Pradaxa stops thrombin, a clotting enzyme. This same action that keeps blood clots at bay also can cause internal bleeding.

At least 260 people had fatally bled out after taking Pradaxa by November 2010. Another 540 patients using Pradaxa died in 2011. in 2012, Boehringer Ingelheim warned that internal bleeding from Pradaxa was irreversible and that there was no reversal agent available at that time.

Yet, the company allegedly had developed an antidote even before blood thinner Pradaxa was approved to be sold in the United States, but did not seek approval of the antidote until years later. Boehringer Ingelheim’s Praxbind went on the market in the fall of 2015.

Blood Thinner Pradaxa Touted as Superior to Coumadin

Boehringer Ingelheim declared Pradaxa was so safe that it didn’t require blood monitoring.

Pradaxa marketers were attempting to prove the drug’s superiority over the previous go-to blood thinner medication Coumadin, which requires blood tests every one to four weeks to ensure optimal levels are maintained.

Coumadin has been used for more than 50 years, and most side effects can be controlled through monitoring and the use of vitamin K, which minimizes bleeding problems.

While the need for blood monitoring might be inconvenient, Coumadin might be safer for patients who are endangered by the “one size fits all” recommended dosing of Pradaxa.

Boehringer Ingelheim documents were discovered in 2014 that showed employees became concerned that the medical community would read an internal research paper and decide Pradaxa patients could have medication levels better controlled with blood monitoring. Pradaxa’s big selling point had been that no blood tests were needed to maintain a proper therapeutic level. Employees allegedly feared losing that competitive edge.

Boehringer Ingelheim has faced thousands of lawsuits from patients who have taken blood thinner Pradaxa and suffered gastrointestinal, rectal, or brain bleeding injuries. Some of the lawsuits have been filed by relatives of those who have lost family members to fatal bleeding allegedly caused by Pradaxa.

Even though the company agreed to a $650 million settlement to resolve 4,000 lawsuits, blood thinner Pradaxa brought in $2 billion for Boehringer Ingelheim.

If you or someone you know has experienced serious adverse effects from blood thinner Pradaxa, you could benefit from speaking with an attorney.

In general, Pradaxa lawsuits are filed individually by each plaintiff and are not class actions.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Pradaxa attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Pradaxa class action lawsuit is best for you. Hurry — statutes of limitations may apply.

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